Device Recall dissector PlasmaKnife (DPK)

  • Model / Serial
    Lot Numbers: 0805064, 0805102, 0805103, 0806030, 0806039, 0806187, and 0807021
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Canada, UK, Italy, Spain, Norway, Australia, and Taiwan.
  • Product Description
    Gyrus ACMI, Inc. dissector PlasmaKnife (DPK) || Catalog No: 7035-3005 || A single use only bipolar electrosurgical instrument with the ability to cut and coagulate soft tissue in head and neck surgery within an ambient air environment.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Gyrus ACMI Corporation, 136 Turnpike Road, Southborough MA 01772
  • Manufacturer Parent Company (2017)
  • Source
    USFDA